blood pressure control of nifedipine gits 60mg treatment in chinese hypertensive subjects uncontrolled on starting-dose mono-therapyo-therapy.

Conditions: Hypertension

Summary: to evaluate antihypertensive efficacy and tolerability of nifedipine gits 60mg treated for 8 weeks in chinese hypertensive subjects who failed to achieve bp control with the starting-dose antihypertensive monotherapy.

study design: it's a a prospective, open-label, multicenter, single-arm study. after a one- to two-week screening period, subjects receive nifedipine gits 60mg for 8 weeks. the primary objective is to evaluate the antihypertensive efficacy of 8-week nifedipine gits 60mg treatment in chinese hypertensive subjects who failed to achieve bp control with the starting-dose antihypertensive mono-therapy. the secondary objective is to evaluate the tolerability of nifedipine gits 60mg.

Eligibility criteria:
inclusion criteria: * subjects are eligible to be included in the study only if they meet all of the following criteria: * aged 18 years or older, but less than 65 years; * either male or female * bp is uncontrolled after at least 4 weeks of prior antihypertensive mono-therapy (the dosage of mono-therapy should be the starting dose of an angiotensin receptor blocker (arb), angiotensin converting enzyme inhibitor (acei), b-blocker (bb), calcium channel blocker (ccb), or diuretic) both in the beginning and at the end of the screening period (uncontrolled bp is defined as mssbp ≥140 and \<160mmhg and/or msdbp ≥ 90 and \<100mmhg, and in the presence of diabetes mellitus: mssbp ≥130 and \<160mmhg and/or msdbp ≥80 and \<100mmhg); exclusion criteria: * subjects meeting any of the following criteria are to be excluded from the study: * known hypersensitivity to nifedipine or to any of the following excipients, hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, iron oxide red (e172/c.i.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (e171/c.i.77891) * evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc. severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy) * evidence of cardiovascular shock * pregnant, possibly pregnant, planning to become pregnant or lactating women received combination (two or more than two drugs combination) therapy or higher dosage (a higher dosage is defined as a higher dosage than the standard recommended starting dosage presented in the label of each drug) mono-therapy in the beginning or at the ending of the screening period. * history of cerebrovascular ischemic event (stroke or transient ischemic attack \[tia\]) within 6 months * history of intracerebral hemorrhage or subarachnoid hemorrhage * history of hypertensive retinopathy * any history of heart failure, new york heart association (nyha) classification iii or iv severe coronary heart disease as manifested by a history of myocardial infarction or unstable angina in the past 12 months or a history of percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) * clinically significant cardiac valvular disease * history of arrhythmia * type 1 diabetes mellitus (dm) * hyperkalemia history: a serum potassium level above the upper limit of normal in the laboratory range; * liver disease or aspartate transaminase (ast) or alanine transaminase (alt) levels \>3 x upper limit of normal (uln) * renal insufficiency, defined as estimated glomerular filtration rate (egfr) of \<30 ml/min, or on hemodialysis